Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to be launched as CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules

Delivers more “Good On” time with less frequent dosing compared to Immediate Release CD/LD

CREXONT commercial launch planned in September 2024

BRIDGEWATER, N.J., August 7, 2024 -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). CREXONT is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets.

“The approval of CREXONT is a seminal moment in the treatment paradigm for Parkinson’s disease. The burden of this incurable neurodegenerative disease increases with time. Some PD patients on IR CD/LD take up to 10 daily doses and still experience motor fluctuations. CREXONT’s innovative formulation provides a longer duration of “Good On” time with less frequent dosing compared to IR CD/LD. Amneal is so excited to introduce this meaningful new treatment for Parkinson’s patients in the U.S. and soon internationally. We are committed to continuing to advance Parkinson’s research and development as a leader in the space,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.

Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily “Good On” time, defined as “On” time without troublesome dyskinesia, as the disease progresses. There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One new patient is diagnosed with Parkinson’s disease every six minutes. In the treatment of PD, there is a need for improved oral CD/LD formulations that achieve more “Good On” time with fewer daily doses.

•More “Good On” time with less frequent dosing: CREXONT demonstrated a statistically significant improvement of 0.5 hours of additional “Good On” time per day compared to IR CD/LD, with an average of three times a day dosing with CREXONT compared to five times a day dosing with IR CD/LD, in the RISE-PD clinical trial. A post-hoc analysis of the primary endpoint on a per dose basis showed 1.6 hours additional “Good On” time per dose of CREXONT, compared to IR CD/LD.

•Novel formulation designed to provide long lasting efficacy: CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER pellets with levodopa for long-lasting efficacy.

•Safety profile consistent with IR CD/LD: The most common adverse reactions with CREXONT (incidence ≥3% and greater than IR CD/LD) are nausea and anxiety. See Important Safety Information below.

“The treatment goals for people living with Parkinson’s disease include achieving a more robust duration of benefit per dose of LD, reducing ‘Off’ time, and simplifying dosing regimens. CREXONT’s longer ‘Good On’ time per day and per dose represents a substantial advancement in managing motor symptoms and maintaining more consistent therapeutic effects, which is very encouraging for both patients and the Parkinson’s community,” said Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida and Director of the Parkinson's Disease and Movement Disorders Center.

“People living with Parkinson’s disease experience a notable decrease in quality of life over time and they experience more ‘Off’ time and other side effects. As the PD community explores treatment options that address the challenges faced by people with Parkinson's disease and their families, we champion advances like CREXONT that improve ‘Good On' time, allowing people more time to do the things they love with the people they love,” said Andrea Merriam, Chief Executive Officer of Parkinson & Movement Disorder Alliance. 

Amneal expects to make CREXONT available to patients in the U.S. in September 2024.

CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER pellets with levodopa for long-lasting efficacy. CREXONT formulation and dosage strengths are different from RYTARY® (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015.

CREXONT (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.

•Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.

•Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.

•CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery, until you know how CREXONT affects you.

•The most common side effects that may occur with CREXONT are nausea and anxiety.

•Avoid sudden discontinuation or rapid dose reduction with CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.

•You may take CREXONT with or without food; but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.

•Swallow CREXONT whole. Do not chew, divide, or crush the capsules.

•Do not take CREXONT with alcohol.

Tell your healthcare provider if you:

•Have any heart conditions, especially if you have had a heart attack or irregular heartbeats.

•Experience hallucinations or abnormal thoughts and behaviors.

•Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges.

•Have thoughts of suicide or have attempted suicide.

•Have abnormal involuntary movements that appear or get worse during treatment.

•Have ever had a peptic ulcer or glaucoma.

•Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm.

•Are breastfeeding during therapy.

•Have side effects; your doctor can adjust your dose.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the full Prescribing Information here: www.amneal.com/pi/crexont.pdf. For more information talk to your healthcare provider.

Parkinson’s disease (PD) has become the fastest growing neurological disorder worldwide, with approximately 1 million people diagnosed in the U.S.1,2 It is a progressive disorder of the central nervous system (CNS) that affects dopamine-producing neurons in the brain that affect movement. PD is characterized by slowness of movement, stiffness, resting tremor and impaired balance.3 While PD is not considered a fatal disease, it is associated with significant morbidity and disability.4 The average age at diagnosis for people with PD is 60; as people live longer, the number of people living with PD is predicted to grow significantly over the coming decades.1,5

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

1.Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.

2.Marras et al. NPJ Parkinson’s Dis. 2018;4:21.

3.NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019.

4.Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.

5.Johns Hopkins Medicine. Young-Onset Parkinson’s Disease.

 

Investor Contact
Anthony DiMeo
VP, Investor Relations & Media
anthony.dimeo@amneal.com

Media Contact
Rachel Girard

Senior Director, Media and Engagement, Real Chemistry

rgirard@realchemistry.com

Amneal Medical Affairs
888-990-AMRX (2679)
askamrx@amneal.com

‒ CREXONT® U.S. FDA approval represents an exciting new long-term growth driver ‒

BRIDGEWATER, NJ, August 9, 2024 - Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the second quarter ended June 30, 2024.

“Amneal achieved strong revenues and adjusted EBITDA in the second quarter, and we are pleased to raise full year 2024 guidance driven by broad-based growth across our business. Amneal is a diversified and growing global pharmaceuticals company built on our core strengths in quality, innovation and operational execution. Coupled with this week’s approval of CREXONT for Parkinson’s disease, Amneal is well positioned to continue delivering durable long-term growth. We are excited about the big opportunities ahead as we focus on the most important areas of medicine to create value for patients, providers and all stakeholders,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

Net revenue in the second quarter of 2024 was $702 million, an increase of 17% compared to $599 million in the second quarter of 2023. Generics net revenue increased 14% driven primarily by biosimilars and new product launches. Specialty net revenue increased 7% driven by promoted products in Neurology and Endocrinology. AvKARE net revenue increased 33% driven by continued growth across its sales channels.

Net income attributable to Amneal Pharmaceuticals, Inc. was $6 million in the second quarter of 2024 compared to $12 million in the second quarter of 2023.

Adjusted EBITDA in the second quarter of 2024 was $162 million, an increase of 11% compared to the second quarter of 2023, reflective of strong revenue performance partially offset by the impact of business mix on gross margins and higher commercial spend to support new products.

Diluted income per share in the second quarter of 2024 was $0.02 compared to $0.08 for the second quarter of 2023, primarily due to lower net income. Adjusted diluted earnings per share in the second quarter of 2024 was $0.16 compared to $0.19 for the second quarter of 2023 due to the aforementioned factor.

The Company presents GAAP and adjusted (non-GAAP) quarterly results. Please refer to the “Non-GAAP Financial Measures” section for more information. In the tables provided below, GAAP to non-GAAP reconciliations are presented.

The Company is raising its previously provided full year 2024 guidance.

			Updated Guidance			Prior Guidance
Net revenue			$2.70 billion - $2.80 billion			$2.55 billion - $2.65 billion
Adjusted EBITDA (1)			$610 million - $630 million			$580 million - $620 million
Adjusted diluted EPS (2)			$0.57 - $0.63			$0.53 - $0.63
Operating cash flow (3)			$280 million - $320 million			$260 million - $300 million
Capital expenditures			$60 million - $70 million			$60 million - $70 million

(1) Includes 100% of Adjusted EBITDA from the AvKARE acquisition.

(2)Accounts for 35% non-controlling interest in AvKARE. Updated guidance and prior guidance assume weighted-average diluted shares outstanding of approximately 320 million and 317 million for the year ending December 31, 2024, respectively.

(3) Does not contemplate one-time and non-recurring items such as legal settlements and other discrete items.

Amneal’s 2024 estimates are based on management’s current expectations, including with respect to prescription trends, pricing levels, the timing of future product launches, the costs incurred and benefits realized of restructuring activities, and our long-term strategy. The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable measures in accordance with GAAP without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments, legal settlements, and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results.

Amneal will host a conference call and live webcast at 8:30 am Eastern Time today, August 9, 2024, to discuss its results. The live webcast and presentation will be accessible through the Investor Relations section of the Company’s website at https://investors.amneal.com. To access the call through a conference line, dial (833) 470-1428 (in the U.S.) with access code 462066. A replay of the conference call will be posted shortly after the call and will be available for seven days. For a list of toll-free international numbers, visit this website: https://www.netroadshow.com/events/global-numbers?confId=52762.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S.

federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income and adjusted diluted EPS, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Adjusted diluted EPS reflects diluted earnings (loss) per share based on adjusted net income (loss), which is net loss adjusted to (A) exclude (i) non-cash interest, (ii) GAAP provision for (benefit from) income taxes, (iii) amortization, (iv) stock-based compensation, (v) acquisition, site closure expenses, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to certain legal matters, including interest, net, (viii) asset impairment charges, (ix) change in fair value of contingent consideration, (x) increase in tax receivable agreement liability, (xi) system implementation expense, (xii) other and (xiii) net income attributable to non-controlling interests not associated with our Class B common stock, and (B) include non-GAAP provision for income taxes. Non-GAAP adjusted diluted EPS for the three and six months ended June 30, 2024 was calculated using the weighted average fully diluted shares outstanding of Class A common stock. Non-GAAP adjusted diluted EPS for the three and six months ended June 30, 2023 was calculated using the weighted average diluted shares outstanding of Class A common stock and assuming all shares of Class B common stock were converted to shares of Class A common stock as of January 1, 2023.

Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance. The compensation committee of the Company’s board of directors also uses certain of these measures to evaluate management’s performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management.

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is set forth below.

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

(1)Following the implementation of the Reorganization on November 7, 2023, all outstanding shares of Old PubCo Class A Common Stock and Old PubCo Class B Common Stock were exchanged for an equivalent number of shares of Class A common stock of the Company. Refer to Note 1. Nature of Operations and Note 8. (Loss) Earnings per Share to the consolidated financial statements in the Company’s 2023 Annual Report on Form 10-K for additional information.

(1)Acquisition, site closure, and idle facility expenses for the three and six months ended June 30, 2024 primarily included rent for vacated properties. Acquisition, site closure, and idle facility expenses for the three and six months ended June 30, 2023 primarily included site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility.

(2)For the six months ended June 30, 2024, charges related to legal matters, net were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the United States.

(3)System implementation expense for the three and six months ended June 30, 2024 and 2023 was primarily for the implementation of software to further integrate our acquired businesses.

(4)The non-GAAP effective tax rates for the three and six months ended June 30, 2024 were 25.7% and 25.1%, respectively. The non-GAAP effective tax rates for the three and six months ended June 30, 2023 were 22.5% and 22.6%, respectively.

(5)Weighted average diluted shares outstanding for the three and six months ended June 30, 2024 consisted of fully diluted Class A common stock. Weighted average diluted shares outstanding for the three and six months ended June 30, 2023 consisted of diluted Class A common stock and Class B common stock, as if all shares of Class B common stock were converted to Class A common stock as of January 1, 2023.

(1)Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)Adjustments for the three months ended June 30, 2024 and 2023, respectively, were comprised of stock-based compensation expense ($0.9 million and $0.3 million), amortization expense ($10.5 million and $10.8 million), site closure and idle facility expenses (none and $1.0 million), and asset impairment charges (none and $1.3 million).

(3)Adjustments for the three months ended June 30, 2024 and 2023, respectively, were comprised of stock-based compensation expense ($1.0 million and $2.0 million) and site closure costs ($0.6 million in each period).

(4)Adjustments for the three months ended June 30, 2024 and 2023 were comprised of stock-based compensation expense.

(1)Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)Adjustments for the six months ended June 30, 2024 and 2023, respectively, were comprised of stock-based compensation expense ($1.8 million and $2.0 million), amortization expense ($20.9 million and $21.6 million), site closure and idle facility expenses (none and $3.1 million), asset impairment charges ($1.0 million and $2.0 million), and other (none and $0.1 million).

(3)Adjustments for the six months ended June 30, 2024 and 2023, respectively, were comprised of stock-based compensation expense ($2.3 million and $2.7 million) and site closure costs ($1.0 million and $1.2 million).

(4)Adjustments for the six months ended June 30, 2024 and 2023 were comprised of stock-based compensation expense.

(5)Adjustments for the six months ended June 30, 2024 were associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the United States.

(1)Adjustments for the three months ended June 30, 2024 and 2023 were comprised of amortization expense.

(2)Adjustments for the three months ended June 30, 2024 and 2023 were comprised of stock-based compensation expense.

(3)Contingent consideration was recorded in connection with the acquisitions of (i) the baclofen franchise from certain entities affiliated with Saol International Limited and (ii) Kashiv Specialty Pharmaceuticals, LLC.

(1)Adjustments for the six months ended June 30, 2024 and 2023 were comprised of amortization expense.

(2)Adjustments for the six months ended June 30, 2024 and 2023 were comprised of stock-based compensation expense.

(3)Contingent consideration was recorded in connection with the acquisitions of (i) the baclofen franchise from certain entities affiliated with Saol International Limited and (ii) Kashiv Specialty Pharmaceuticals, LLC.

(1)Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)Adjustments for the three months ended June 30, 2024 and 2023 were comprised of amortization expense.

(1)Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)Adjustments for the six months ended June 30, 2024 and 2023, respectively, were comprised of amortization expense ($7.1 million and $8.4 million) and other (none and ($0.4) million).